Lab Values
This lab value is commonly monitored to detect or monitor the progression of prostate cancer
Prostate Specific Antigen(PSA)
This institutional system houses all Reg files and TMF for protocols.
Advarra eREG
In the EPIC AE module, Adverse Events are routed to this team member for sign off and finalization.
Treating MD
any expected or unexpected adverse event, related or unrelated to the therapy being studied, that results in any of the following outcomes: death, a life-threatening adverse event, requires inpatient hospitalization (not required as part of the treatment) or prolongation of existing hospitalization, a persistent or significant disability or incapacity, or cancer, or a congenital anomaly or birth defect.
Serious Adverse Event (SAE)
Anemia can be caused by low levels of this blood cell count
Hemoglobin (Hb)
****Monitoring Visit logs are saved to this system
Advarra eREG/ Sharepoint for older trials that are not transitioned to Advarra eReg
filing of SAE communication with sponsor/supporter are kept in this system
Advarra eREG
A meeting that prepares a research site for a clinical trial. Held between a study sponsor's representative and the research team at a potential clinical trial site, where the protocol, procedures, and study details are reviewed to ensure the site is prepared to begin enrolling patients in the study
site initiation visit (SIV)
This AE means there is an abnormally low amount of platelets.
Thrombocytopenia
the ongoing periodic evaluation of a research study by an Institutional Review Board (IRB) after initial approval, where the IRB assesses the study's progress, safety of participants, and adherence to the protocol at designated intervals throughout the study duration, typically on an annual basis, to ensure ethical conduct and participant protection.
Continuing Reviews
An RNI is submitted in this system.
These 4 categories of responses can be given as a RECIST response.
When Potassium (K) levels are low, this Adverse Event should be logged.
Hypokalemia
All GU study SAE logs are maintained in this system
Prometheus
advocated to control bias that might result from errors in progression assessments. Has driven the requirement to have scans read by a central group of radiologists who are blinded to treatment arm, the local investigator assessment of progression and other clinical outcomes.
blinded, independent, central review (BICR)
low Sodium (Na) levels often result in this adverse event to be documented.
hyponatremia
A group of doctors, scientists, and other experts that reviews the detailed plan of a clinical trial for scientific quality and correct study design.
Scientific Review Committee (SRC)